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Arena Pharmaceuticals, Inc.

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Supreme Court Seems Ready To Uphold Ruling Against Amgen’s Anti-PCSK9 Antibody Patents

Justices question what Amgen’s invention covers in its dispute with Sanofi. They appear inclined to uphold Federal Circuit’s standard for enablement despite potential negative impact on genus claims.

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At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion

Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.

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Novartis’s Kisqali Strikes Gold In Adjuvant Early Breast Cancer Setting

The Swiss major’s CDK4/6 inhibitor has met the primary endpoint in a pivotal breast cancer trial earlier than expected, with success in the intermediate risk group representing a $4bn opportunity untapped by rival Eli Lilly.

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